Approval to add steri-tek (smart world llc) located at 48225 lakeview boulevard, fremont, california 94538, as a new e-beam sterilization site for the mynxgrip vascular closure device (5f/6f/7f).
| Device | MynxGrip Vascular Closure |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ACCESS CLOSURE, INC. |
| Date Received | 2018-05-16 |
| Decision Date | 2018-07-10 |
| PMA | P040044 |
| Supplement | S081 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ACCESS CLOSURE, INC. 5452 Betsy Ross Drive santa Clara, CA 95054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040044 | | Original Filing |
| S093 |
2022-09-29 |
30-day Notice |
| S092 |
2022-06-02 |
30-day Notice |
| S091 |
2022-03-31 |
30-day Notice |
| S090 |
2021-11-19 |
30-day Notice |
| S089 | | |
| S088 |
2021-10-08 |
30-day Notice |
| S087 |
2021-10-07 |
30-day Notice |
| S086 |
2021-09-01 |
30-day Notice |
| S085 |
2019-09-03 |
30-day Notice |
| S084 |
2019-04-24 |
30-day Notice |
| S083 |
2019-02-12 |
30-day Notice |
| S082 |
2018-08-27 |
30-day Notice |
| S081 |
2018-05-16 |
Normal 180 Day Track No User Fee |
| S080 |
2018-04-02 |
30-day Notice |
| S079 |
2018-02-05 |
Normal 180 Day Track |
| S078 |
2017-11-20 |
Normal 180 Day Track |
| S077 |
2017-06-30 |
Real-time Process |
| S076 |
2017-05-01 |
30-day Notice |
| S075 |
2016-11-21 |
135 Review Track For 30-day Notice |
| S074 |
2016-08-29 |
30-day Notice |
| S073 |
2016-06-06 |
30-day Notice |
| S072 |
2016-04-04 |
30-day Notice |
| S071 | | |
| S070 |
2016-01-07 |
Real-time Process |
| S069 |
2016-01-05 |
30-day Notice |
| S068 |
2015-12-07 |
Normal 180 Day Track No User Fee |
| S067 | | |
| S066 |
2015-09-09 |
Real-time Process |
| S065 |
2015-07-09 |
30-day Notice |
| S064 |
2015-07-02 |
30-day Notice |
| S063 |
2015-03-25 |
30-day Notice |
| S062 |
2014-12-19 |
Real-time Process |
| S061 |
2014-12-12 |
30-day Notice |
| S060 |
2014-12-12 |
30-day Notice |
| S059 |
2014-11-12 |
Real-time Process |
| S058 |
2014-10-30 |
30-day Notice |
| S057 |
2014-05-23 |
Real-time Process |
| S056 |
2014-05-02 |
Normal 180 Day Track |
| S055 |
2014-04-10 |
30-day Notice |
| S054 |
2014-04-03 |
Real-time Process |
| S053 |
2014-04-01 |
30-day Notice |
| S052 |
2014-03-31 |
30-day Notice |
| S051 |
2014-03-31 |
30-day Notice |
| S050 |
2013-12-26 |
30-day Notice |
| S049 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S048 |
2013-02-22 |
Real-time Process |
| S047 |
2012-12-31 |
Normal 180 Day Track |
| S046 |
2012-12-26 |
30-day Notice |
| S045 |
2012-11-14 |
Normal 180 Day Track No User Fee |
| S044 |
2012-11-06 |
Real-time Process |
| S043 |
2012-02-08 |
Real-time Process |
| S042 |
2011-12-13 |
30-day Notice |
| S041 |
2011-11-21 |
30-day Notice |
| S040 |
2011-11-14 |
Real-time Process |
| S039 |
2011-08-29 |
135 Review Track For 30-day Notice |
| S038 |
2011-05-27 |
Normal 180 Day Track No User Fee |
| S037 |
2011-03-10 |
Real-time Process |
| S036 |
2011-02-10 |
30-day Notice |
| S035 | | |
| S034 |
2010-09-30 |
Normal 180 Day Track |
| S033 |
2010-08-18 |
Real-time Process |
| S032 |
2010-05-20 |
Special (immediate Track) |
| S031 |
2010-04-02 |
30-day Notice |
| S030 |
2010-04-01 |
30-day Notice |
| S029 |
2010-03-29 |
30-day Notice |
| S028 |
2010-03-04 |
30-day Notice |
| S027 |
2010-02-22 |
Special (immediate Track) |
| S026 |
2010-02-19 |
30-day Notice |
| S025 |
2010-02-12 |
135 Review Track For 30-day Notice |
| S024 |
2009-12-14 |
30-day Notice |
| S023 |
2009-10-29 |
30-day Notice |
| S022 |
2009-10-27 |
30-day Notice |
| S021 |
2009-10-23 |
Real-time Process |
| S020 |
2009-10-22 |
30-day Notice |
| S019 |
2009-09-30 |
30-day Notice |
| S018 | | |
| S017 |
2009-07-21 |
30-day Notice |
| S016 |
2009-07-15 |
Real-time Process |
| S015 |
2009-06-25 |
Special (immediate Track) |
| S014 |
2009-04-14 |
Special (immediate Track) |
| S013 |
2009-04-13 |
30-day Notice |
| S012 |
2009-03-19 |
Special (immediate Track) |
| S011 |
2009-02-17 |
Real-time Process |
| S010 |
2008-11-13 |
Real-time Process |
| S009 |
2008-06-04 |
30-day Notice |
| S008 |
2008-06-03 |
Real-time Process |
| S007 |
2008-03-31 |
Normal 180 Day Track No User Fee |
| S006 |
2008-03-14 |
Special (immediate Track) |
| S005 |
2008-03-11 |
135 Review Track For 30-day Notice |
| S004 |
2007-11-16 |
Special (immediate Track) |
| S003 |
2007-10-05 |
30-day Notice |
| S002 |
2007-08-24 |
Special (immediate Track) |
| S001 |
2006-04-06 |
Panel Track |
NIH GUDID Devices